Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis - Full Text View

Sponsor:	Procter and Gamble
Information provided by:	Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00041756

Purpose

Matrix metalloproteinases have been implicated in the cartilage degradation that occurs in osteoarthritis. PG-530742 inhibits some of these matrix metalloproteinases, thus potentially limiting cartilage degradation and disease progression. This study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate knee osteoarthritis.

Condition	Intervention	Phase
Osteoarthritis, Knee	Drug: PG-530742 Drug: Placebo tablet, Drug: 50 mg PG-530742 Drug: 100 mg PG-530742 Drug: 200 mg PG-530742	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:

Minimum joint space width in teh medial compartment of the tibiofemoral joint of the knee at one year [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment:	401
Study Start Date:	January 2002
Study Completion Date:	February 2004
Primary Completion Date:	February 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo tablet	Drug: Placebo tablet, One placebo tablet, twice daily for for one year
2: Experimental 25 mg PG-530742	Drug: PG-530742 One 25 mg PG-530742, twice daily for for one year
3: Experimental 50 mg PG-530742	Drug: 50 mg PG-530742 One 50 mg PG-530742, twice daily for for one year
4: Experimental 100 mg PG-530742	Drug: 100 mg PG-530742 100 mg PG-530742 tablet, twice a day for one year
5: Experimental 200 mg PG-530742	Drug: 200 mg PG-530742 200 mg PG-530742 tablet, twice a day for one year

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

mild to moderate knee osteoarthritis confirmed by a radiographic technique.

Exclusion Criteria:

secondary knee osteoarthritis;
diseases other than osteoarthritis that could cause knee pain;
any disease or intervention (surgery, intra-articular injection) that would have an impact on knee pain or mobility;
drugs that act potentially on the bone or cartilage component of the knee joint.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041756

Locations

Hungary
National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology IV., Frankel Leo u. 38-40
Budapest, Hungary, 1027
Szent Ferenc Hospital, Department of Rheumatology, Csabai Kapu 42.
Miskolc, Hungary, 3529
National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology I and Metabolic Osteology, Frankel Leo u. 38-40
Budapest, Hungary, 1027
Orthopedic Clinic, Karolina ut 17
Budapest, Hungary, 1113
National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology and Immunology, Frankel Leo u. 38-40
Budapest, Hungary, 1027
Hungary, Gizella telep
Rehabilitation Hospital, Gizella telep
Visegrad, Gizella telep, Hungary, 2026
Hungary, Hid Utica 2
Petz A. Country Hospital, Department of Rheumatology, Hid utca 2.
Gyor, Hid Utica 2, Hungary, 9025
United Kingdom
Dept of Rheumatology Dulwich Hospital, East Dulwich
London, United Kingdom, SE22 8PT
Dept of Rheumatology Whipps Cross University Hospital, Whipps Cross Road
London, United Kingdom, E11 1NR
Rheumatology Department, Fourth Floor, Thomas Guy House, St Guy's House
London Bridge, United Kingdom, SE1 9RT
Synexus Wrightington, Wrightington Hospital, Hall Lane, Awpley Bridge
Wigan, United Kingdom, WN6 9EW
Hildenborough Medical Group, Trenchwood Surgery, 264 Shipbourne Road
Tonbridge, United Kingdom, TN10 3ET
Dept of Rheumatology Selly Oak Hospital, Raddleburn Road, Selly Oak
Birmingham, United Kingdom, B29 6JD
Synexus Birmingham Clinical Research Centre, Birmingham Research Park
Edgbaston, United Kingdom, B15 2SQ
Grosvenor Medical Centre Clinical Trials Unit, 18 upper Grosvenor Road, Tunbridge Wells
Kent, United Kingdom, TN 1 2DX
Synexus Reading Clinical Research Centre, Whiteley Glebe, 11 Glebe Road, off Christchurch Gardens
Reading, United Kingdom, RG2 7AG
United Kingdom, Middlesex
95 Stanwell Road
Ashford, Middlesex, United Kingdom, TW15 3EA
Royal National Orthapaedic Hsopital, Brackley Hill
Stanmore, Middlesex, United Kingdom, HA 7 4LP
United Kingdom, Se17eh
St Thomas Hospital, Lambeth Place Road
London, Se17eh, United Kingdom
United Kingdom, Surrey
The Crouch Oak Practice, 45 Station Road, Addlestone
Addlestone, Surrey, United Kingdom, KT15 2BH
The Medical Centre, Kingston Avenue
East Horsley, Surrey, United Kingdom, KT24 6QT
United Kingdom, Warwickshire
Bridge House Medical Centre, Scholars Lane
Stratford-upon-avon, Warwickshire, United Kingdom, CV37 6HE
United Kingdom, West Sussex
Pound Hill Surgery, 1 Crawley Lane, Pound Hill
Crawley, West Sussex, United Kingdom, RH10 7DX

Sponsors and Collaborators

Procter and Gamble

Investigators

Study Director:

John Beary, MD

Procter and Gamble

More Information

No publications provided by Procter and Gamble

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Krzeski P, Buckland-Wright C, Bálint G, Cline GA, Stoner K, Lyon R, Beary J, Aronstein WS, Spector TD. Development of musculoskeletal toxicity without clear benefit after administration of PG-116800, a matrix metalloproteinase inhibitor, to patients with knee osteoarthritis: a randomized, 12-month, double-blind, placebo-controlled study. Arthritis Res Ther. 2007;9(5):R109.

Responsible Party:	Procter and Gamble Pharmaceuticals ( John Beary, MD )
Study ID Numbers:	2001065
Study First Received:	July 16, 2002
Last Updated:	July 17, 2009
ClinicalTrials.gov Identifier:	NCT00041756 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Procter and Gamble:

Primary Disease: Knee Primary Osteoarthritis

Additional relevant MeSH terms:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on March 18, 2010